United States· US:65044-0831_3c14e8ca-64c9-463f-963d-5a2e31d01ad3
Standardized Grass Pollen, Timothy
A medicinal product containing phleum pratense pollen, registered in United States by Jubilant HollisterStier LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- PHLEUM PRATENSE POLLEN
- Manufacturer
- Jubilant HollisterStier LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 8
- ndc1165044-0831-3
- ndc1165044-0831-4
- ndc1165044-0831-1
- ndc1165044-0831-2
- ndc1165044083115 mL in 1 VIAL (65044-0831-1)
- ndc11650440831210 mL in 1 VIAL (65044-0831-2)
- ndc11650440831330 mL in 1 VIAL (65044-0831-3)
- ndc11650440831450 mL in 1 VIAL (65044-0831-4)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Phleum pratense pollen in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandAlutard SQ Phleum pratense
- United KingdomGrass mix pollen 5HEP solution for skin prick testDiater
- CanadaALLERGENIC EXTRACT - STANDARDIZED GRASS POLLEN - TIMOTHYGREER LABORATORIES INC
- NetherlandsAlutard SQ Phleum pratense 100 - 100.000 SQ-E/ml, suspensie voor injectieALK-Abello A/S
- CzechiaALUTARD SQ BOJÍNEKALK-Abelló A/S, Horsholm
- FranceGRAZAX 75 000 SQ-T, lyophilisat sublingualALK ABELLO (DANEMARK)
- GermanyPrick Test Lieschgras LetiLeti Pharma Gmbh
- ItalyGRAZAX*orale 30 liofilizzati 75.000SQ-TALK-ABELLO' A/S
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Austria · Oraltek, Prick Test Lieschgras Leti
- Germany · Prick Test Lieschgras Leti, Provokationstest Lieschgras Leti
- Netherlands · Bencard, Prick Test Pollen Hal Allergy
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/b913ee9a-f678-4977-960f-7d706cb5ffb8 GET /v1/drugs/b913ee9a-f678-4977-960f-7d706cb5ffb8?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "PERCUTANEOUS; SUBCUTANEOUS",
"source": "ndc",
"strength": "10000",
"substance": "PHLEUM PRATENSE POLLEN",
"productndc": "65044-0831",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "[BAU]/mL",
"application_number": "BLA103879",
"marketing_category": "BLA"
}See everything about phleum pratense pollen.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.